BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRLNE BLU 4X24IN 7-0 D/A BV-1

    MDR report key: 23010556 · Received September 9, 2025

    Report

    Report Number
    2210968-2025-10273
    Event Type
    Malfunction
    Date Received
    September 9, 2025
    Date of Event
    January 1, 2025
    Manufacturer
    ETHICON INC.
    Product Code
    GAW
    UDI-DI
    10705031045774
    PMA / PMN Number
    K133356
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4) THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS PROVIDED PLEASE CONFIRM THE NUMBER OF PATIENTS AFFECTED BY THIS ALLEGED DEFICIENCY. UNKNOWN. HAVE ANY OF THESE EVENTS BEEN PREVIOUSLY REPORTED TO ETHICON? IF SO, PROVIDE THE RESPECTIVE REFERENCE NUMBER(S). NOT TO MY KNOWLEDGE IF NO, PLEASE CREATE A NEW PC FILE FOR EACH PATIENT/EVENT. WHEN DID THE SUTURE BREAKAGE HAPPEN (REMOVAL FROM PACKAGE / DURING HANDLING PRIOR TO USE ON PATIENT/ DURING PASSAGE THROUGH TISSUE / DURING TYING / POST-OP)? DURING THE HANDLING ON THE PATIENT'S TISSUE HOW MANY SUTURES BROKE? PLEASE SPECIFY BY PRODUCT CODE AND LOT NUMBER: I WAS TOLD SEVERAL BUT WAS NOT GIVEN A SPECIFIC NUMBER WHEN DID THE NEEDLE POPPED OFF FROM THE SUTURE THREAD (REMOVAL FROM PACKAGE / DURING HANDLING PRIOR TO USE ON PATIENT/ DURING PASSAGE THROUGH TISSUE / DURING TYING / POST-OP)? DURING THE CASE. HOW MANY NEEDLES POPPED OFF? PLEASE SPECIFY BY PRODUCT CODE AND LOT NUMBER: THEY DID NOT SPECIFY. PLEASE PROVIDE THE LOT NUMBER OF PRODUCTS M8737 AND M8702. THESE LOTS WERE NOT ABLE TO BE RETRIEVED. THE OUTER PACKAGING WAS THROWN OUT BEFORE THEY REPORTED TO ME., PLEASE NOTE THESE SUTURES CAME IN THE MEDLINE PACK AND DID NOT COME OFF THE SHELF¿.IT WAS NOTED BY THE TECH THAT THIS HAPPENS OFTEN WITH SUTURES THAT ARE REPACKED INTO THE MEDLINE PACKS. WERE THERE PATIENT CONSEQUENCES? IF YES, PLEASE EXPLAIN. THEY HAD TO RESTART THE ANASTOMOSIS WITH A FRESH SUTURE FROM OFF THE SHELF. LONGER PROCEDURE TIME. NO ISSUES AFTER RETRIEVING A NEW STITCH PROVIDE THE SOURCE OR NAME AND TITLE OF EXTERNAL PERSON PROVIDING ANSWERS TO FOLLOW-UP (EXTERNAL PERSON SUBMITTING ANSWERS TO SALES REP). SCRUB TECH DID NOT WANT TO GIVE NAME: D4: UDI: AS THE LOT NUMBER FOR THE DEVICE INVOLVED IN THE EVENT WAS NOT PROVIDED, THE FULL UDI IS CURRENTLY NOT AVAILABLE. TO DATE IT HAS BEEN REPORTED THAT THE DEVICE WILL NOT BE RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. H6 COMPONENT CODE: G07002 ¿ DEVICE NOT RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A CABG PROCEDURE IN 2025 AND SUTURE WAS USED. THE SUTURES ARE BREAKING MID STRAND AND NEEDLE HAS POPPED OFF THE SUTURES DURING USE. THEY HAD TO RESTART THE ANASTOMOSIS WITH A FRESH SUTURE FROM OFF THE SHELF. LONGER PROCEDURE TIME. NO ISSUES AFTER RETRIEVING A NEW STITCH. ADDITIONAL INFORMATION WAS REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2826797 PRLNE BLU 4X24IN 7-0 D/A BV-1 SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE GAW ETHICON INC. 10705031045774

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown